A Quantitative, Cross-Sectional and Observational Study to Characterize Age-Related Structural Changes in Facial Skin of Chinese Women Using Line-Field Confocal Optical Coherence Tomography (LC-OCT)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age20-70
SponsorChinaNorm

About this trial

This is a single-center, non-interventional, observational, cross-sectional clinical study designed to quantitatively and qualitatively characterize skin properties in a cohort of 100 Chinese female Subjects aged 20 to 70 years. The study involves no product application and poses minimal risk to participants. The primary objectives are to establish a comprehensive skin aging profile database, characterize skin color, aging signs, and biomechanical properties, and create a histomorphometric database for the development and validation of ordinal photographic scales for aging research. Data will be collected through questionnaires, clinical assessments (including LC-OCT imaging), standardized photography, and non-invasive biophysical measurements. All procedures will be conducted in accordance with the ethical principles originating from the Declaration of Helsinki, the International Council for Harmonisation Good Clinical Practice (ICH-GCP) guidelines, and the relevant laws and regulations of China (including the \*Measures for the Ethical Review of Biomedical Research Involving Human Subjects\*). All data will be anonymized and stored securely.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Chinese female, aged between 20 and 70 years (inclusive) at the time of signing consent.

Willing and able to provide written informed consent.

Fitzpatrick Skin Phototype II or III.

Willing to comply with all study procedures, including removal of facial makeup and avoidance of intensive skincare (e.g., retinoids, strong acids) on the test areas for 3 days prior to the visit as per instructions.

Disqualifiers

Pregnant, planning pregnancy, or breastfeeding (as hormonal changes significantly affect skin properties).

Presence of temporary tanning, sunburn, or significant erythema on the face or measurement areas.

Presence of facial piercings, tattoos, too much fluff or significant scarring that would interfere with imaging or measurements in the areas of interest.

History of any aesthetic or surgical procedure on the face (e.g., laser therapy, chemical peels, injectable fillers, botulinum toxin, plastic surgery) within the past 12 months.

Trial population

Approximately 100 healthy Chinese female Subjects, evenly distributed across age groups (20-29, 30-39, 40-49, 50-59, 60-70 years).

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

100 Participants
are grouped into 5 trial groups
Group A: Group 20 to 29 Years old
Group B: Group 30 to 39 Years old
Group C: Group 40 to 49 Years old
Group D: Group 50 to 59 Years old
Group E: Group 60 to 69 Years old

Trial outcomes

Primary outcomes

1

Epidermal Thickness

Time frame
Single visit, day 1
2

Dermal-Epidermal Junction (DEJ) Undulation Index

Time frame
Single visit, day 1
3

Mean Dermal Reflectivity

Time frame
Single visit, day 1
4

Stratum Corneum Thickness

Time frame
Single visit, day 1

Secondary outcomes

1

Clinician-graded score of skin texture/pores

Time frame
Single visit, day 1
2

Clinician-graded score of skin pigmentation

Time frame
Single visit, day 1
3

Clinician-graded score of facial wrinkles

Time frame
Single visit, day 1

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.